FLEX NEEDLE
Device Facts
| Record ID | K961049 |
|---|---|
| Device Name | FLEX NEEDLE |
| Applicant | Lighthouse Medical, Inc. |
| Product Code | FPA · General Hospital |
| Decision Date | Sep 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Intended Use
The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports.
Device Story
FlexNeedle™; intravascular administration set for subdermally implanted venous access ports. Components: flexible catheter, hub with elastomeric septum and side port, sideleg tubing with luer infusion fitting, cap, pinch clamp, insertion stylet. Used by clinicians for port access; provides bloodstream access via hollow tube/luer fitting. Facilitates infusion/access; benefits patient by enabling reliable port utilization.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Flexible catheter, hub with elastomeric septum, sideleg tubing, luer infusion fitting, cap, pinch clamp, insertion stylet. Intravascular administration set design.
Indications for Use
Indicated for patients requiring transcutaneous cannulation of subdermally implanted venous access ports for bloodstream access.
Regulatory Classification
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Predicate Devices
- Luther Medical Products L-CATH for Ports
- Medex SureCath Port Access Catheter
- SIMS Deltec Gripper
Related Devices
- K990693 — FLEXNEEDLE PLUS · Act Medical, Inc. · May 14, 1999
- K972712 — CORE RESISTANT HUBER INFUSION SETS · Icu Medical, Inc. · Oct 1, 1997
- K981683 — HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y · Venusa , Ltd. · Jul 28, 1998
- K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE · Kawasumi Laboratories Co., Ltd. · Mar 14, 1997
- K955587 — VASCULAR ACCESS PORT KIT · Boston Scientific Corp · Mar 21, 1996
